Guidance on the application of EN 29001 and EN 46001 and EN 29002 and EN 46002 for the active (including active implantable) medical device industry; German version EN 50103:1995— 17 стр.
Quality management and quality assurance standards - Part 1: Guidelines for selection and use (ISO 9000-1:1994); Trilingual version EN ISO 9000-1:1994— 47 стр.
Quality management and quality assurance standards; part 3: guidelines for the application of ISO 9001 to the development, supply and maintenance of software; identical with ISO 9000-3:1991— 34 стр.
Quality systems; model for quality assurance in design/development, production, installation and servicing (identical with ISO 9001:1987); EN 29001:1987— 21 стр.
Sterilization of medical devices - Validation and routine control of sterilization by irradiation (includes Corrigendum 1:1999 (A1:1999) and Amendment A2:2000); German version EN 552:1994 + Corrigendum 1:1999 (A1:1999) + Amendment A2:2000— 29 стр.
Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software (ISO 9000-3:1997); Bilingual version EN ISO 9000-3:1997— 43 стр.
